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Alvotech Snags Australian Approval for Adalimumab Biosimilar


Iceland-based Alvotech received regulatory approval for AVT02, its biosimilar referencing Humira (adalimumab), from the Therapeutic Goods Administration of Australia.

The Australian Therapeutic Goods Administration granted marketing authorization for AVT02 (Ciptunec, Ardalicip), an adalimumab biosimilar referencing Humira developed by Alvotech, for the treatment of several rheumatic conditions.

It is the seventh adalimumab biosmilar to be approved in Australia. There are currently 43 approved biosimilars in the country.

The product, a tumor necrosis factor inhibitor, was approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, psoriasis, hidradenitis suppurativa, and uveitis.

“We are very pleased about the marketing authorization in Australia, following approval and successful launches of Alvotech’s high concentration biosimilar to Humira in multiple markets in Europe and Canada. As we are dedicated to improving global access to affordable biologics, we welcome this step in our journey,” said Mark Levick, CEO of Alvotech, in a company statement.

The biosimilar will be marketed by Cipla Australia as part of a commercialization agreement between Cipla and Alvotech in July 2019. In November 2020, the companies extended their partnership to include South Africa. In January 2021, the partnership was expanded to include Australia and New Zealand markets for 4 additional biosimilar candidates under development with Alvotech. Ciptunec/Ardalicip is the first product developed as part of the partnership to receive Australian regulatory approval.

“The first approved biosimilar in Cipla’s partnership with Alvotech marks an important milestone. We look forward to extending our footprint in the biosimilars market by increasing the availability of cost-effective high-concentration low-volume adalimumab for Australian patients,” commented Nishant Saxena, CEO of international business in Europe and emerging markets at Cipla.

When it launches in Australia, the biosimilar will be offered as a 40 mg/0.4 mL and 80 mg/0.8 mL solution in a prefilled syringe and a 40 mg/0.4 mL solution in a prefilled pen, which could be easier for patients to self-administer. The biosimilar is also a high-concentration formulation and is citrate-free.

Ciptunex/Ardalicip has also been approved in the European Union, Norway, Iceland, Liechtenstein, the United Kingdom, Switzerland, Canada, and Saudi Arabia. In Switzerland it is marketed as Hukyndra and in Canada and Saudi Arabia as Simlandi. AVT02 is also under review with the FDA and is expected to launch in July 2023 in the United States with an interchangeability designation.

Other Alvotech News

In addition to the Australian approval, Alvotech announced that another one of its partners, Fuji Pharma, has submitted an application for the approval of a biosimilar to the Japanese Ministry of Health, Labor and Welfare.

“I want to congratulate our partners at Fuji for reaching this important milestone…. Our partnership is based on a joint commitment to increase patient access to vital biologic medicines, and we believe we are well positioned to serve the growing need for biosimilars in Japan,” said Robert Wessman, founder and executive chairman of Alvotech, in a statement.

Alvotech and Fuji Pharma entered into an exclusive partnership in November 2018 and extended it in December 2020 and February 2022 to cover 6 proposed biosimilars for the Japanese market. The molecules included in the agreement have not been disclosed.

Additionally, Alvotech and JAMP Pharma expanded their partnership to add 2 more biosimilar candidates (AVT16, AVT33) for the Canadian market. AVT16 will be used in the immunology space and AVT33 would be an oncology product. Simlandi is the other product included in the agreement.

“The partnership with JAMP Pharma will allow us to accelerate towards establishing a leadership position in the Canadian biosimilars market…. Our mission is to broaden and simplify access to new biosimilars for patients around the world,” commented Wessman.

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